Telix (ASX:TLX) has announced that the primary results from its Phase 3 ZIRCON trial have been published in The Lancet Oncology.
The publication reports that Telix's first-in-class investigational PET agent, TLX250-CDx (Zircaix), is highly accurate in detecting and characterising clear cell renal cell carcinoma (ccRCC) in patients with indeterminate renal masses (IRMs).
In this peer-reviewed manuscript, Professor Brian Shuch of the University of California and colleagues report results from this prospective, open-label, multicentre, Phase 3 trial in which 300 patients received TLX250-CDx.
Authors conclude that TLX250-CDx "has a favourable safety profile and is a highly accurate, non-invasive imaging modality for the detection and characterisation of ccRCC, which has the potential to be practice-changing."
Authors explain that small masses in the kidney are increasingly being detected incidentally when patients undergo abdominal imaging, often for other health conditions, contributing to "an era of gross overtreatment".
Diagnosis and treatment are limited by current imaging techniques, and renal mass biopsy is invasive, which can often lead to complications.
Up to 30 per cent of patients undergo unnecessary surgery, removing masses that are later determined to be benign. If confirmed, however, ccRCC is the most common and aggressive form of kidney cancer, and delays in diagnosis can significantly reduce survival rates.
TLX250-CDx is a radiolabelled monoclonal antibody that targets carbonic anhydrase IX, a tumour-associated antigen highly expressed in ccRCC.
Following successful Phase 1 and 2 trials to establish safety and preliminary efficacy, the ZIRCON trial assessed the sensitivity and specificity of TLX250-CDx PET/CT imaging to detect ccRCC in patients who underwent nephrectomy non-invasively.
Telix chief medical officer Dr David Cade said, "The results of the ZIRCON trial make a compelling case for TLX250-CDx as a breakthrough product for kidney cancer imaging, and validate CAIX as a novel target to accurately identify renal cell carcinoma.
"Professor Shuch and his co-investigators, at 36 sites worldwide, found that its high diagnostic performance, including for very small lesions, may support early and accurate diagnosis, inform patient risk stratification and clinical decision making, and reduce over- and under-treatment. We believe this result will lead to improved patient outcomes."
